Sage Q Care Continue Care Kit Recalled for Incorrect Expiration Date
Sage Products Inc is recalling 640 Q Care Continue Care Kits because the kit's printed expiration date is incorrect. The kits contain oral care products with an earlier expiration date than printed on the main kit.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
Sage Products Inc is voluntarily recalling 640 units of the Q Care Continue Care Kit for the non-ventilated patient. The recall is due to a labeling error where the expiration date printed on the kit is November 13, 2017, rather than the correct date of August 28, 2017. The correct expiration date of August 28, 2017, is printed on the individual Corinz Antiseptic Cleansing & Moisturizing Oral Rinse packages included in the kit.
The affected product is identified by Lot 59123 and was distributed nationwide in the USA. The kit contains one Covered Yankauer, two Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, and two Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. The product is prescription-only.
Consumers who have this product should stop using it and contact Sage Products Inc for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride)
- Manufacturer
- Sage Products Inc
- Category
- Medical Device — Oral Care
- Hazard
- Affected units
- 640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 59123
- Exp 11/13/17
Distribution
Distributed nationwide across the United States.
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